FDA 510(k) Application Details - K974248

Device Classification Name	System, Monitoring, Perinatal   More FDA Info for this Device
510(K) Number	K974248
Device Name	System, Monitoring, Perinatal
Applicant	AIR-SHIELDS, INC. 330 JACKSONVILLE RD. HATBORO, PA 19040 US Other 510(k) Applications for this Company
Contact	MARCI L GOLDFINGER Other 510(k) Applications for this Contact
Regulation Number	884.2740   More FDA Info for this Regulation Number
Classification Product Code	HGM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/12/1997
Decision Date	10/07/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review